Oral Desensitization to Peanut in Peanut Allergic Children and Adults Using CPNA Peanut OIT Safety Follow-On Study

Peanut Allergy Clinical Trial

Official title:

Oral Desensitization to Peanut in Peanut-Allergic Children and Adults Using Characterized Peanut Allergen (CPNA) Peanut Oral Immunotherapy (OIT) Safety Follow-On Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198664
• Other study ID #: ARC002
• Status: Completed
• Phase: Phase 2
• Start date: August 27, 2014
• Est. completion date: January 4, 2018

Study information

• Verified date: November 2021
• Source: Aimmune Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, open-label, follow-on study to gather additional information on the safety and tolerability of oral desensitization with CPNA in the subjects who participated in ARC001.

Description:

This phase 2, open-label, follow-on, multicenter study was designed to gather additional information on the safety, tolerability, and efficacy of oral desensitization with AR101 in subjects who participated in study ARC001 (NCT01987817) as follows:

• Group 1 (ARC001 placebo): Subjects who received placebo in study ARC001

• Group 2 (ARC001 AR101): Subjects who received AR101 and tolerated up to 300 mg peanut protein (443 mg cumulative) in the DBPCFC at the end of study ARC001

All subjects will receive daily oral dosing of peanut OIT (oral immunotherapy) in the form of Characterized Peanut Allergen (CPNA).

Study Duration - 12-90 weeks before reaching the Extended Maintenance Phase. All Subjects may continue Extended Maintenance Phase until CPNA becomes commercially available or the study is terminated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 4, 2018
• Est. primary completion date: January 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 26 Years

Eligibility

Key Inclusion Criteria:

• Completion of ARC001 study

• No change in the status of any longitudinally applicable ARC001 inclusion criteria

Key Exclusion Criteria:

• Early termination from ARC001

• Failure to tolerate 300 mg of peanut protein in the ARC001 exit food challenge

• A lapse in dosing of more than 10 days from completion of ARC001

• Change in the status of any longitudinally applicable ARC001 exclusion criteria

Related Conditions & MeSH terms

• Peanut Allergy
• Peanut Hypersensitivity

Intervention

Biological:
• AR101 - Peanut protein capsule
Study product provided as peanut protein in pull-apart capsules at 5 dosage strengths (0.5, 1, 10, 100, and 475 mg) or sachets at 2 dosage strengths (300 and 1000 mg)

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of North Carolina Chapel HIll	Chapel Hill	North Carolina
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Children's Medical Center Dallas	Dallas	Texas
United States	Arkansas Children's Hospital	Little Rock	Arkansas
United States	Mount Sinai Medical Center	New York	New York
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	UC San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Aimmune Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-related Adverse Events and Dosing Symptoms Occurring With Peanut OIT Over a Protracted Treatment Period Comprising at Least 18 Months	TEAEs are any event starting during or after the active treatment period. If a subject has multiple occurrences of TEAEs, the subject is presented once in the respective subject count (n).	Up to 90 weeks
Secondary	The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg) and 600 mg (1043 mg Cumulative) Peanut Protein With no More Than Mild Symptoms During the Up-dosing DBPCFC		Up to 36 weeks
Secondary	The Proportion of Subjects Who Tolerated at Least 300 mg (443 mg), 600 mg (1043 mg Cumulative), and 1000 mg Peanut Protein (2043 mg Cumulative) With no More Than Mild Symptoms During the Maintenance DBPCFC.		Up to 60 weeks.
Secondary	Change From Baseline in the Single Highest Tolerated Dose of Peanut Protein	The single highest tolerated dose of peanut protein with no more than mild symptoms during the up-dosing DBPCFC and the change from baseline was evaluated for the ARC001 placebo completer population. The single highest tolerated dose of peanut protein with no more than mild symptoms during the maintenance DBPCFC and the change from up-dosing DBPCFC was evaluated for each group (ARC001 AR101 and ARC001 placebo) and overall for the food challenge completer population.	Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Secondary	Number of Participants Who Tolerated Maximum Dose of Peanut Protein With no More Than Mild Symptoms Maximum Dose of Peanut Protein Tolerated	The maximum dose of peanut protein tolerated with no more than mild symptoms during the up-dosing and maintenance DBPCFCs	Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Secondary	Change in Peanut-specific IgE From Baseline and Up-dosing to Extended Maintenance		Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Secondary	Change in Peanut-specific IgG4 From Baseline and Up-dosing to Extended Maintenance		Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Secondary	Change in Skin Prick Test (SPT) Mean Peanut Wheal Diameter and Peanut Erythema/Flare From Baseline and Up-dosing to Extended Maintenance		Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)
Secondary	Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Up-Dosing DBPCFC	Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during up-dosing DBPCFC	Up to 36 weeks for up-dosing
Secondary	Number of Participants With Maximum Symptom Severity at Each Challenge Dose of Peanut Protein in All Subjects During Maintenance DBPCFC	Maximum severity of symptoms that occurred at each challenge dose of peanut protein for all subjects during maintenance DBPCFC	Up to 60 weeks (Up to 36 weeks for up-dosing; up to 24 weeks for maintenance)
Secondary	Change in Physician Global Assessment, Disease Activity as Measured on a 100 mm Visual Analogue Scale (VAS) From Baseline and Up-dosing to Extended Maintenance.	A 100-mm Visual Analog Scale (VAS) was used by the investigators for the Physician Global Assessment of disease activity as a marker for safety. The investigator was to assign a single integrated overall disease activity score ranging from 0 to 100 mm. Zero indicated no disease activity and 100 indicated very severe disease activity.	Baseline, Up-dosing (up to 36 weeks), Extended Maintenance (up to 90 weeks)